Effect of Predilatation Methods on Drug Coated Balloon Treatment in In-Stent Restenosis Lesions

Abstract

Background: Even in the modern drug eluting stent (DES) era, in stent restenosis (ISR) is still the problem and existing treatment options are debatable. Among these, treatment with drug coated balloon (DCB) can be promising on long term outcomes. However the predilatation methods before DCB are controversial. Objective: The aim of this study is to evaluate whether the methods of predilatation (lesion preparation) before DCB treatment can affect the outcomes in ISR cases. Methods: Between 2014-2017, 101 patients were treated with DCB for ISR cases. Among these, 66 patients (65.3%) were followed up for CAG (coronary angiography) assessment. These patients were divided into two groups; scoring balloon group (n = 40) and non-scoring balloon group (n= 26). Primary endpoint was the target lesion revascularization (TLR) at follow up. We also compared QCA (quantitative coronary angiography) assessment for every procedure: before the procedure, after the procedure and during follow up. Then these QCA parameters were compared thoroughly between two groups. Results: Total seventeen cases (25.8%) were found to have TLR. These TLR rates were 20.0% in Scoring balloon group and 34.6% in Non-scoring balloon group (p value = 0.18). In QCA analysis after the procedure and during follow up, minimal lumen diameter was higher, % diameter stenosis and % area stenosis were significantly lower in scoring balloon group than non-scoring balloon group. For the specific predilatation groups, TLR rates were 16.1% in cutting balloon group, 33.3% in non-slip element (NSE) balloon group and 45.0% in non-compliant (NC) balloon group respectively. In our subgroup analysis, TLR rates were 34.4% in hemodialysis patients and 17.6% in non-hemodialysis patients (p value = 0.03). RCA (right coronary artery) proximal segment had the highest TLR rate (53.8 %) compared with the other groups - RCA mid to distal, LCX (left circumflex) and LAD (left anterior descending) with 25.0%, 8.3% and 17.6% respectively (p value = 0.009). Conclusions: Regarding the predilatation methods before DCB treatment in ISR cases, scoring balloon especially cutting balloon is more superior to the non-scoring balloon in terms of TLR and QCA assessment.